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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K974672
Device Name MSI SURGICAL DRAPES
Applicant
Medical Specialty Innovations, Inc. (Msi)
55 Northern Blvd.
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
Medical Specialty Innovations, Inc. (Msi)
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA
Regulation Number878.4370
Classification Product Code
KKX  
Date Received12/15/1997
Decision Date 03/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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